Welcome to our dedicated page for Fortress Biotech news (Ticker: FBIO), a resource for investors and traders seeking the latest updates and insights on Fortress Biotech stock.
Fortress Biotech, Inc. (Nasdaq: FBIO) is a biopharmaceutical company that regularly issues news about its portfolio of prescription pharmaceutical products and development programs. Its press releases cover updates from Fortress itself and from majority-owned and partner companies that it has founded or supports, providing investors with a consolidated view of activity across oncology, dermatology and rare disease assets.
Recent announcements highlight regulatory milestones, clinical progress and transaction-driven events. Fortress and its majority-owned subsidiary Cyprium Therapeutics have reported U.S. Food and Drug Administration (FDA) approval of ZYCUBO (copper histidinate, formerly CUTX-101) for the treatment of Menkes disease in pediatric patients, noting that it is the first and only FDA-approved treatment for Menkes disease in the United States. Earlier updates described FDA acceptance of the resubmission of the New Drug Application for CUTX-101 and the transfer of development and commercialization responsibilities to Sentynl Therapeutics, with Cyprium eligible for royalties and milestone payments.
News related to Journey Medical Corporation, which was founded by Fortress, includes financial results driven by net revenues from dermatology products and the commercial launch of Emrosi (DFD-29) for inflammatory lesions of rosacea in adults. Releases also present clinical data, such as pooled Phase 3 analyses demonstrating Emrosi’s efficacy versus comparators, and discuss payer access and prescription trends.
Additional Fortress news items describe monetization events and pipeline updates, such as the acquisition of Checkpoint Therapeutics by Sun Pharma, the sale of dotinurad rights to Crystalys Therapeutics with associated equity and royalty interests, and the initiation of Phase 3 trials of dotinurad for gout by Crystalys. Investors following FBIO news can use this page to review these types of announcements, track regulatory interactions, and monitor how Fortress’ subsidiaries and partners contribute to the overall portfolio.
Checkpoint Therapeutics reported Q3 2024 financial results and updates. The FDA set a PDUFA goal date of December 28, 2024 for their cosibelimab BLA review. The company received $9.2 million from warrant exercises in November, extending cash runway into 2025. Q3 financials show cash position of $4.7 million, R&D expenses of $6.4 million (up from $5.5M YoY), and G&A expenses of $3.4 million (up from $2.2M YoY). Net loss was $9.7 million ($0.23 per share) compared to $5.7 million ($0.29 per share) in Q3 2023. The company presented promising longer-term data for cosibelimab in cSCC at ESMO Congress 2024.
Journey Medical (DERM) reported Q3 2024 financial results with total revenues of $14.6 million, marking a 4% decrease from Q3 2023. The company received FDA approval for Emrosi™, a treatment for inflammatory lesions of rosacea in adults, with launch expected in late Q1 or early Q2 2025. Q3 2024 showed a net loss of $2.4 million ($0.12 per share), compared to net income of $16.8 million in Q3 2023. Gross margin improved to 63.9% from 57.9% year-over-year. The company ended the quarter with $22.5 million in cash and cash equivalents.
Journey Medical (Nasdaq: DERM) has received FDA approval for Emrosi™, a 40 mg minocycline hydrochloride extended-release capsule for treating inflammatory lesions of rosacea in adults. The approval is backed by successful Phase 3 clinical trials where Emrosi demonstrated superior efficacy compared to both Oracea® 40 mg capsules and placebo. The trials met all co-primary and secondary endpoints with no significant safety concerns. Journey Medical plans to launch Emrosi in the U.S. market through its dermatology-focused sales force, with initial supply expected late Q1 or early Q2 2025.
Journey Medical (Nasdaq: DERM) presented data on DFD-29, a minocycline-based treatment for rosacea, at the 44th Fall Clinical Dermatology Conference. The study compared DFD-29 (40mg) with doxycycline (40mg) over 21 days, showing DFD-29 achieved higher dermal concentrations from Day 1. The company's New Drug Application is under FDA review with a PDUFA date of November 4, 2024. The randomized study demonstrated that DFD-29's modified-release formulation maintained consistent plasma levels while providing superior skin penetration compared to doxycycline, with both treatments showing good tolerability.
Journey Medical (Nasdaq: DERM), a commercial-stage pharmaceutical company specializing in FDA-approved prescription drugs for dermatological conditions, has announced its participation in the 3rd Annual ROTH Healthcare Opportunities Conference. The event is set to take place on Wednesday, October 9, 2024, in New York City.
Members of Journey Medical's management team will be attending one-on-one meetings during the conference. This participation highlights the company's commitment to engaging with investors and industry professionals in the healthcare sector.
The conference provides an opportunity for Journey Medical to showcase its focus on selling and marketing dermatological treatments, potentially attracting investor interest and fostering business relationships within the pharmaceutical industry.
Fortress Biotech, a biopharmaceutical company focused on acquiring and advancing assets, announced its participation in two upcoming investor conferences in October 2024. Lindsay A. Rosenwald, M.D., the company's Chairman, President, and CEO, will represent Fortress at these events:
1. Lytham Partners Fall 2024 Investor Conference on October 1, 2024, at 4:15 p.m. ET. This virtual event will feature a fireside chat and 1x1 meetings.
2. 3rd Annual ROTH Healthcare Opportunities Conference on October 9, 2024, in New York, consisting of 1x1 meetings.
A replay of the Lytham Partners fireside chat will be available on Fortress Biotech's website for approximately 30 days after the event.
Fortress Biotech (Nasdaq: FBIO) has announced a registered direct offering and concurrent private placements totaling approximately $8 million in gross proceeds. The company will issue 3,939,394 shares of common stock (or pre-funded warrants) at $1.65 per share to healthcare-focused institutional investors, along with warrants to purchase an additional 3,939,394 shares at $1.84 per share. In a separate private placement, the company's Chairman, CEO, and President purchased 763,359 shares at $1.84 per share and warrants for the same number of shares.
The offerings are expected to close around September 23, 2024. Fortress Biotech plans to use the net proceeds for operations, including research and development, clinical trials, and working capital. A.G.P./Alliance Global Partners is acting as the sole placement agent for the offerings.
Checkpoint Therapeutics presented longer-term data from its pivotal trial of cosibelimab, an anti-PD-L1 antibody, for advanced cutaneous squamous cell carcinoma (cSCC) at the ESMO Congress 2024. Key highlights include:
- Increased objective response rates (ORRs) of 54.8% and 50.0% in locally advanced and metastatic cSCC, respectively
- Complete response rates improved to 25.8% and 12.8% in locally advanced and metastatic cSCC
- Median duration of response not yet reached in either group
- Manageable safety profile with low rates of severe immune-related adverse events
Checkpoint's Biologics License Application for cosibelimab is under FDA review with a PDUFA goal date of December 28, 2024. The company believes cosibelimab's efficacy and safety profile could position it as a preferred immunotherapy for advanced cSCC if approved.
Journey Medical (Nasdaq: DERM), a commercial-stage pharmaceutical company specializing in FDA-approved dermatological treatments, has announced its participation in the Lake Street Capital Markets 8th Annual Best Ideas Growth (BIG) Conference. The event is set to take place on Thursday, September 12, 2024 in New York City.
Claude Maraoui, President and CEO of Journey Medical, will be attending the conference to engage in one-on-one meetings with investors and industry professionals. This participation underscores the company's commitment to growth and investor relations in the pharmaceutical sector, particularly in the field of dermatology.
Fortress Biotech (Nasdaq: FBIO), an innovative biopharmaceutical company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. Lindsay A. Rosenwald, M.D., the company's Chairman, President, and CEO, will present a corporate overview at the event. The presentation will be available for on-demand viewing by conference attendees starting on September 9, 2024, at 7:00 a.m. ET.
Fortress Biotech focuses on acquiring and advancing assets to enhance long-term shareholder value through various revenue streams, including product revenue, equity holdings, and dividend and royalty revenue. The company will also participate in one-on-one meetings during the conference, providing an opportunity for more in-depth discussions with investors and industry professionals.